Senior Associate, Cell Therapy Manufacturing

Job Description

Job Description

At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. Our commitment to innovation, patient-centered focus, and scientific excellence drives us to develop groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care). 

Position Summary:

Responsible for the execution of process steps to manufacture commercial cell therapy products meeting internal and regulatory requirements.

Schedule: This position is onsite 5 days a week in our new Burlington, MA office, but will be required to spend some days in our Cambridge office as we transition to our new facility. The two available shifts are Sun-Wed or Wed-Sat.

Position Scope:

• Perform manufacturing procedures inside a manufacturing clean room in accordance with established SOPs, cGMPs, and safety regulations. 
• Qualified to perform aseptic manipulations of cell culture operations.
• Able to make cell-culture decisions based on cell observations and guidelines in written procedures.
• Document all operations in Electronic Batch Records and log sheets according to cGMPs and established SOPs.
• Maintain manufacturing-controlled areas in an inspection ready state. Perform clean room equipment sanitization.
• Record equipment and facility metrology data to ensure the equipment operates within specifications. Report out of specification readings to production management.
• Demonstrated proficiency in organizing small groups and teams, to deliver key initiatives and small projects.
• Effectively use time management and collaboration across the team to seek out opportunities to ensure delivery of the Manufacturing Team’s daily tasks.
• Work with influence and rapport across the Team. Be receptive to feedback and guidance from manager and other more experienced staff.
• Build and grow our teams through collaboration and positive interactions. Demonstrated influence and leadership qualities, to directly support the Team Leads. The ability to cooperate with others in a team environment will be critical to success.
• Practice safe work habits and adhere to Vericel’s safety procedures and guidelines.
• Assist in reviewing and revising production documents (SOP’s and electronic records).
• Ability to identify and report deviations, lead GEMBA interviews and contribute to deviation investigations.
• In addition to being fully qualified in MACI or Epicel manufacturing process, cross train and qualify in at least 5 core competenciese.g.3T3, Media Prep,D365 ERP, TrackWise, Veeva.
• Achieve and maintain approved Qualified Trainer status for at least 3 Operations. Be receptive to feedback and coaching on your presence and methods for training, as well as support efforts to drive consistency and standardization on operational methodology.
• Serve as a technical resource for questions and /or investigate manufacturing issues.
• Collaborate with Production Planners to ensure schedule accuracy
• Communicate patient lots status with Customer Care team
• Other duties as assigned.

Basic Qualifications:

• Bachelor’s or higher degree (Life Sciences or related field) or equivalent with3+years of experience with Vericel operations with demonstrated behaviors associated with the role (Internal) or 4+ years of experience working in a cGMP environment in the biotech or pharmaceutical industry.
• HS Diploma/GED with 4+ Years of experience with Vericel operations with demonstrated behaviors associated with the role (Internal) or with 5+ years of experience working in a cGMP environment in the biotechnology or pharmaceutical industry.
• Excellent communication skills, written and verbal.
• Experience with Microsoft Office suite.
  
  

Preferred Qualifications:

• Biotechnology certificate that includes hands-on laboratory courses.
• Experience in small scale tissue culture processing.
• Experience working within a regulated environment that is frequently audited by internal and external Agencies, such as the FDA and ISO.

Why Vericel?

• Cutting-Edge Science: Work with a leading regenerative medicine product that is transforming patient care.
• Career Growth: Be a part of a growing organization with opportunities to expand your impact.
• Collaborative Culture: Work alongside a team of dedicated professionals who are passionate about improving lives.

The hourly wage range Vericel reasonably and in good faith expects to pay for this position at the time of this posting is $31.00 to $36.00 per hour.

The actual salary offered will be determined based on factors such as the candidate’s qualifications, experience, and skills. Bonus, incentive pay, equity and benefits may be provided in addition to the base compensation listed above.

In accordance with Massachusetts law, Vericel provides the pay range that it reasonably and in good faith expects to pay for a particular and specific employment position at the time of posting or offer. This range is subject to change based on business needs, market conditions, and individual qualifications. Employees and applicants may request the pay range for their position or for a position to which they are applying. Retaliation for making such a request is strictly prohibited.

EEO Statement

All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer.

Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.